home edit2 whole TSD November 2002 PDF format - OEHHA

Table 1.
Experimental design of 2,4-diaminotoluene carcinogenicity bioassay using male
and female F344 rats and B6C3F 1 mice (NCI, 1979)
Sex/species Study group dietary
2,4-diaminotoluene
(ppm)
Study time
(weeks)
Time-weighted
average dose c
(ppm)
Male rat matched control 0 103 0
low dose 125 40
50 63 79
high dose 250 40
100 39 a 176
Female rat matched control 0 103 0
low dose 125 40
50 63 79
high dose 250 40
100 44 b 171
Male,female matched control 0 101
mouse low dose 100 101
high dose 200 101
a. Test diet administration was terminated at the time indicated and all high-dose males were killed
because of morbidity.
b. Test diet administration was terminated at the time indicated and all high-dose females except
four were killed because of morbidity.
∑ (dose in ppm × weeks at that dose)
c. Time-weighted average dose = ∑ (weeks receiving each dose)
Significantly increased tumor incidences were observed in treated rats; hepatocellular adenomas,
carcinomas and neoplastic nodules in male and female rats, mammary gland adenomas and carcinomas
in female rats, and subcutaneous fibromas in male rats. Significant increases in tumor incidence were
also noted in female mice; hepatocellular carcinomas in the low- and high-dose groups, and lymphomas
in the low-dose group. No significant tumor induction was noted in male mice. Tumor incidence data is
listed in Table 2.
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